# FDA recall D-0165-2020

> **AVKARE Inc.** · Class II · drug recall initiated 2019-10-17.

## Product

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

## Reason for recall

CGMP Deviations: Impurity  N-nitrosodimethylamine (NDMA) found in API

## Distribution

CO, MO

## Key facts

- **Recall number:** D-0165-2020
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-17
- **Report date:** 2019-11-06
- **Termination date:** 2020-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2020

## Citation

> AI Analytics. FDA recall D-0165-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0165-2020. Source: US FDA. Licensed CC0.

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